The FDA granted accelerated approval for Truvada, a fixed-dose combination of Gilead Sciences Inc.'s anti-HIV medications Emtriva and Viread.
Truvada is expected to be on pharmacy shelves next week, James Loduca, manager, public affairs for Foster City, Calif.-based Gilead, told BioWorld Today. It will sell for $650.83 per month (Viread costs $398 per month and Emtriva costs $252.83 per month).
"Truvada will be useful to patients who are looking to add the convenience of combining two of their existing medications into one pill," Loduca said.
Michael King, an analyst with Banc of America Securities LLC, of New York, told BioWorld Today Truvada might cannibalize Viread sales to some extent, but overall, the combination drug will help the Gilead franchise. By 2009, he expects Truvada to reach $1 billion in worldwide sales, compared to $650 million for Viread and $200 million for Emtriva.
Truvada combines 200 mg of Emtriva (emtricitabine) and 300 mg of Viread (tenofovir disoproxil fumarate) in one tablet, taken once a day in combination with other antiretroviral agents. It is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults.
In its second-quarter earnings reported last week, Gilead said sales of Viread rose 18 percent to $197.2 million ($109.2 million in the U.S.) from $167 million last year, while Emtriva (emtricitabine) sales totaled $16.5 million for the second quarter of 2004, up from $12 million in the first quarter of 2004. (See BioWorld Today, Aug. 2, 2004.)
Viread, the first nucleotide reverse transcriptase inhibitor (NRTI) approved for HIV combination therapy, was cleared by the FDA in 2001 and by the European Agency for the Evaluation of Medicinal Products (EMEA) in 2002. It is available as a single 300-mg tablet taken once daily. (See BioWorld Today, Oct. 30, 2001.)
Emtriva is an NRTI for HIV cleared by the FDA and EMEA in 2003. It is available as a single 200-mg capsule that also is taken once daily. (See BioWorld Today, July 3, 2003.)
Meanwhile, Truvada works by blocking reverse transcriptase, an enzyme crucial for viral replication. By interfering with the replication process, Truvada, when combined with other anti-HIV medication, can help lower the amount of HIV, or "viral load" in a patient's body, and increase the number of immune system cells (T cells or CD4 cells). Both of those changes are generally associated with improving a patient's health and decreasing the likelihood of AIDS-related illnesses, the company said.
Gilead said 283 patients have received combination therapy with Emtriva and Viread with either a non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) for 24 to 48 weeks in ongoing clinical studies. Based on those limited data, no new patterns of adverse events were identified and there was no increased frequency of established toxicities.
The company hopes to win approval in Europe in 2005.
In addition to granting approval of Truvada, the FDA also cleared Gilead's request for an alternate trade dress for Truvada for use in the developing world.
The company plans to include Truvada in the Gilead Access Program, an initiative to increase access to anti-HIV medications in the developing world through sale of the company's antiretrovirals at no-profit pricing. Since 2003, the program has offered Viread at a no-profit price in 68 countries - all countries in Africa and 15 other countries designated by the United Nations as "least developed" - that represent 70 percent of the global AIDS epidemic.
Truvada will be sold in the developing world for $29.75 per month, or 99 cents a day, while Viread will be sold for 82 cents a day. (Emtriva is not included in the access program.)
Truvada will be available in the U.S. as a dark-blue, capsule-shaped tablet and as a similarly shaped, light-blue tablet in the developing world.
On Monday the FDA also announced approval of Epzicom (abacavir/lamivudine), a fixed-dose combination treatment for HIV-1, made by London-based GlaxoSmithKline plc.
Like Truvada, Epzicom is indicated for use in combination with other antiretroviral drugs from different classes such as NNRTIs or PIs for the treatment of adults with HIV-1 infection.
Epzicom is a fixed-dose combination of the antiretroviral drugs abacavir sulfate 600 mg and lamivudine 300 mg, both of which are approved individually under the brand names Ziagen (abacavir sulfate) and Epivir (lamivudine). Epzicom's approval is based on a study showing that abacavir dosed once daily had a similar antiviral effect to abacavir dosed twice daily, both in conjunction with lamivudine and with efaviranz, another antiretroviral drug.
Gregory Wade, an analyst with Pacific Growth Equities Inc. in San Francisco, said in a research note that Epzicom is not expected to present significant competition for Truvada, due to hypersensitivity issues associated with abacavir.
Gilead's stock (NASDAQ:GILD) Tuesday fell 13 cents to close at $63.37.